VA106483 Dose Response in Females

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to describe the pharmacokinetics and pharmacodynamics of VA106483 in female subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vantia Ltd

Criteria

Inclusion Criteria:

• Female subjects 40 years and above

• BMI 18 to 32 kg/m2

• Using adequate contraception and providing negative pregnancy tests pre-dose

• In good health as determined by medical history and screening tests

• Subject is willing and able to abstain from alcohol and caffeine-containing food and beverages 72 hours prior to dosing and throughout the study

• Provide written, informed consent

Exclusion Criteria:

• Pregnancy or lactation

• Evidence of serious pathology or diseases including heart, hormone, liver and kidney, psychiatric and neurological problems, including syndrome of inappropriate antidiuretic hormone secretion, polydipsia or diabetes insipidus

• Likely to be hypersensitive to VA106483

• History of any relevant allergy

• Participation in a clinical study within 30 days

• Donation of blood (500 mL) within 60 days prior to dosing

• A history of alcohol abuse or drug addiction

• Positive results for HIV, HBV or HCV or drugs of abuse

• Currently taking any diuretics or clinically significant cytochrome 3A4 inhibitors or inducers

• Use of any non-prescription preparation within 72 hours prior to dosing, with the exception of ibuprofen, and acetaminophen used at recommended doses

• Treatment within the previous 3 months of drugs known to have a well defined potential for hepatoxicity

• Current smokers or recent ex-smokers

• Other protocol defined eligibility criteria may apply